An interventional study of CTC retainer and Essix retainer maxilla in Orthodontics and Retention, sponsored by Region Gävleborg. Completed. Per ClinicalTrials.gov, last updated 2022-08-09.
Sponsored by Region Gävleborg · Not applicable, Interventional, and Treatment
The purpose of this trial is to evaluate and compare stability after orthodontic treatment with an Essix retainer and a bonded cuspid-to-cuspid retainer (CTC), respectively in the mandibular arch and longitudinally follow these patients over time up to 5 years. The patients' perceptions of the two methods are also evaluated with questionnaires during the follow-up period.
A further aim of this study is to analyze the relationship between diagnosis, treatment outcome, treatment time, age at start of treatment and stability with an Essix retainer in the maxilla.
The null hypotheses are:
The study is conducted at the Orthodontic Clinic, Gävle, Sweden and consists of 104 patients. All patients are treated with fixed appliances in the upper and lower jaw (standard .022 straight wire), both with and without extractions. The patients are randomized into two groups with 52 patients in each group (Group A: cuspid-to-cuspid retainer, Group B: Essix retainer).
Dental cast are obtained at the debond appointment (T1) and at the follow-up controls after six months (T2), 18 months (T3) and 60 months (T4) for both groups.
At the visit two weeks in retention and at the follow-up visits after 6, 18 and 60 months the patients assess questionnaires in order to evaluate their experience of retention with the retention device.
Region Gävleborg is the lead sponsor of 14 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
The CTC is bonded directly after debonding. The Essix retainer maxilla is handed out to the patient the same day after removal of fixed appliances. Alginate impressions are taken at the follow-up visits. Questionnaires are completed at the follow-up visits.
Device: CTC retainer · Device: Essix retainer maxilla · Procedure: Alginate impression · Other: Questionnaire
The Essix retainer maxilla and Essix retainer mandible are handed out to the patient the same day after removal of fixed appliances. Alginate impressions are taken at the follow-up visits. Questionnaires are completed at the follow-up visits.
Device: Essix retainer maxilla · Device: Essix retainer mandible · Procedure: Alginate impression · Other: Questionnaire
The CTC retainer consists of 0.8 hard Remanium® wire (Dentaurum, Germany) and is bonded with Tetric Flow (Ivoclar Vivadent, Liechtenstein) to the lower canines directly after debonding.
Also known as: Fixed retainer, Bonded retainer
The Essix retainer is made of 1 mm Essix C+® Plastic (Dentsply, USA) and is handed out to the patient the same day after removal of fixed appliances.
Also known as: Removable retainer, Vacuum-formed retainer
The Essix retainer is made of 1 mm Essix C+® Plastic (Dentsply, USA) and is handed out to the patient the same day after removal of fixed appliances.
Also known as: Removable retainer, Vacuum-formed retainer
Alginate impressions are taken to made the cuspid-to-cuspid and Essix retainers, respectively. Dental casts are obtained at the debond appointment and at the follow-up visits after 6, 18 and 60 months.
A questionnaire is completed at the follow-up visits.
Changes in Tooth Position
Analyses of changes in tooth position on dental casts Little's Irregularity Index (in mm) 0=no crowding/irregularity, higher scores= more crowding/irregularity (worse outcome)
Time frame: Changes in tooth position (Little's Irregularity Index) were analysed 5 years (T4) after debonding (T1)
Patients' Perception
Analyses of patients' perception by validated self-report questionnaires to evaluate experiences of the retention techniques VAS (visual analog scale, 0-100) 0= low satisfaction 100= high satisfaction
Time frame: T4 (5 years follow up)
| Milestone | Group A: CTC Retainer + Essix Retainer | Group B: Essix Retainer + Essix Retainer |
|---|---|---|
| Started | 52 | 52 |
| Completed | 39 | 35 |
| Not completed | 13 | 17 |
Analyses of changes in tooth position on dental casts Little's Irregularity Index (in mm) 0=no crowding/irregularity, higher scores= more crowding/irregularity (worse outcome)
| millimeters | Group A: CTC Retainer + Essix Retainer | Group B: Essix Retainer + Essix Retainer |
|---|---|---|
| Changes in Tooth Position | 0.05 (-0.40 to 0.73) | 0.62 (-0.08 to 1.49) |
Analyses of patients' perception by validated self-report questionnaires to evaluate experiences of the retention techniques VAS (visual analog scale, 0-100) 0= low satisfaction 100= high satisfaction
| score on a scale | Group A: CTC Retainer + Essix Retainer | Group B: Essix Retainer + Essix Retainer |
|---|---|---|
| Patients' Perception | 93 (79 to 98) | 92 (69 to 96) |
Collected over Observation time: 5 years after debonding (T1-T4). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group A: CTC Retainer + Essix Retainer | 0/52 (0%) | 0/52 (0%) | 0/52 (0%) |
| Group B: Essix Retainer + Essix Retainer | 0/52 (0%) | 0/52 (0%) | 0/52 (0%) |
adolescent patients
| Age, Continuous(years) | Group A: CTC Retainer + Essix Retainer | Group B: Essix Retainer + Essix Retainer | Total |
|---|---|---|---|
| Mean | 17.1 ± 1.9 | 17.1 ± 2.4 | 17.1 ± 2.2 |
| Sex: Female, Male(Participants) | Group A: CTC Retainer + Essix Retainer | Group B: Essix Retainer + Essix Retainer | Total |
|---|---|---|---|
| Female | 26 | 26 | 52 |
| Male | 26 | 26 | 52 |
| Ethnicity (NIH/OMB)(Participants) | Group A: CTC Retainer + Essix Retainer | Group B: Essix Retainer + Essix Retainer | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 0 | 0 | 0 |
| Unknown or Not Reported | 52 | 52 | 104 |
| Region of Enrollment(participants) | Group A: CTC Retainer + Essix Retainer | Group B: Essix Retainer + Essix Retainer | Total |
|---|---|---|---|
| Sweden | 52 | 52 | 104 |
No study locations are listed for this record.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — The participant data will be shared on reasonable request.
Ran from Nov 2009 to primary completion in Jan 2021, 134 months.
Results were first posted in Jun 2022, 1 year 4 months after primary completion.
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This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Region Gävleborg